Main Functions And Design Characteristics; Indications; Absolute Contraindications; Relative Contraindications - B. Braun Aesculap Acculan 4 Gebrauchsanweisung/Technische Beschreibung

Aesculap
Small drill GA344
2.2

Main functions and design characteristics

Speed
min. 0 min
Rotational direction Right and left rotation, oscillation
Operating mode Operation with non-periodic load and speed
changes (type S9 pursuant to IEC EN 60034-
1)
Drilling (clockwise/counterclockwise rota-
tion):
■
■
■
■
Medullary reaming (clockwise/counterclock-
wise rotation):
■
■
■
■
Drilling (oscillation):
■
■
■
■
Saw mode with GB891R:
■
■
■
■
Saw mode with GB892R:
■
■
■
■
Electrical systems generally heat up during continual operation. It is
advised to give the system a break after use to cool down, as listed in the
table on operating mode.
4
Acculan 4
®
-1
to max. 1 250 min
60 second application, 60 second pause
6 repetitions
30 min cooling time
Max. Temperature 48 °C
30 second application, 30 second pause
8 repetitions
30 min cooling time
Max. Temperature 48 °C
15 second application, 15 second pause
3 repetitions
30 min cooling time
Max. Temperature 48 °C
30 second application, 60 second pause
4 repetitions
30 min cooling time
Max. Temperature 48 °C
30 second application, 60 second pause
5 repetitions
30 min cooling time
Max. Temperature 48 °C
Heating depends on the tool used and the load. After a certain number of
repetitions, the system should cool down. This procedure prevents system
overheating as well as possible injury to the patient or user.
-1
The user is responsible for the use and adherence to the pause sequence
described.
2.3

Indications

The small drill GA344, combined with the relevant attachment and tool, is
used for separating, removing and shaping bone, hard tissue, cartilage and
the like, as well as bone replacement material, to screw bone pins in and
out, to drive screw tools and to set transfixion wires.
2.4

Absolute contraindications

The product is not licensed for use on the central nervous system or cen-
tral circulatory system.
2.5

Relative contraindications

The safe and effective use of the product greatly depends on influences
which can only be controlled by the user. Therefore the specifications pro-
vided represent framework conditions only.
Clinically successful use of the product is dependent on the knowledge
and experience of the surgeon. The surgeon must decide which structures
it is sensible to treat and take into account the safety and warning infor-
mation contained in these instructions for use.
3.

Safe handling

CAUTION
Federal law restricts this device to sale by, or on order of a physician!
WARNING
WARNING
■
General risk factors associated with surgical procedures are not
described in this documentation.
■
It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■
The operating surgeon must have a thorough understanding of both
the hands-on and conceptual aspects of the established operating
techniques.
►
Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
Risk of injury and material damage if this product
is not used as intended!
►
Use the product only for its intended purpose.
Risk of injury and damage to property due to
improper handling of the product!
►
Follow the instructions for use of all products
used.